Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/16/26 has been entered.
Claims 1-3, 7-9 remain pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over LEE (KR 20130046283) based on the EPO translation as previously cited, in view of newly cited TASKIN (Pub 2016).
Regarding claim 1, LEE discloses a hyaluronic acid catechol conjugate and use thereof (0001) which is used as a cell culture scaffold (tissue regeneration platform) (line 316) comprising coating the surface (forming coating layer) of an artificial material used for medical purposes (scaffold) with a mixed solution comprising hyaluronic acid catechol conjugate (line 124, 197-201, [0082]).
LEE discloses the support can be a medical device such as an implant, artificial joints, bones, blood vessels or valves (all are 3 dimensional) (lines 241-250) and made of a variety of polymer materials (lines 251-252) but does not explicitly disclose a three dimensional scaffold consisting of polycaprolactone.
However, TASKIN discloses 3D polydopamine functionalized coiled micro fibrous scaffolds in which polycaprolactone (PCL) was used to make 3D coiled microfibers (three dimensional scaffold consisting of polycaprolactone) in which the surface was functionalized with catecholic polydopamine (coating layer comprising a catechol compound) (Abs, Fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the polymeric medical devices (scaffolds) coated with catechol of LEE to be a three dimensional scaffold consisting of polycaprolactone as taught by TASKIN because the 3D structure allows for significantly higher cell infiltration depth over time compared to 2D (p. 15868, Cellular Infiltration, Fig 4D) and overcomes the limited porosity of conventional 2D scaffolds that leads to limited proliferation rate as 3D scaffolds have enhanced viability/proliferation after 28 days of culture compared to the 2D ones (Fig 3F) and PCL is one of the most common FDA approved synthetic polymers (p.15870, Discussion paragraph 3).
LEE discloses a hyaluronic acid catechol compound chemical formula (Fig 1), but does not explicitly disclose the formula including a sodium salt.
However, it would have obvious to one of ordinary skill in the art to modify the chemical compound of LEE to include a sodium salt based on the types of cells or tissues being cultured. Additionally, it would have been obvious to try choosing from a finite number of identified, predictable solutions through routine experimentation with a reasonable expectation of success.
Regarding claim 2-3, LEE discloses the coated material can be used as a cell culture scaffold (tissue cells for culture provided, salivary gland is cultured) (line 316) and that neural stem cells can be cultured (line 273). It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. Further, it has been held that "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." Additionally a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP § 2114 and 2115.
The limitation regarding tissue cells and a salivary gland are considered materials worked on or intended use limitations as the device of modified LEE is capable of being used to culture any desired cells or tissues.
Regarding claim 7 LEE discloses a hyaluronic acid catechol conjugate and use thereof (0001) which is used as a cell culture scaffold (tissue regeneration platform) (line 316) comprising coating the surface (forming coating layer) of an artificial material used for medical purposes (scaffold) with a mixed solution comprising hyaluronic acid catechol conjugate (line 124, 197-201, [0082]).
LEE discloses the support can be a medical device such as an implant, artificial joints, bones, blood vessels or valves (all are 3 dimensional) (lines 241-250) and made of a variety of polymer materials (lines 251-252) but does not explicitly disclose a three dimensional scaffold consisting of polycaprolactone.
However, TASKIN discloses 3D polydopamine functionalized coiled micro fibrous scaffolds in which polycaprolactone (PCL) was used to make 3D coiled microfibers (three dimensional scaffold consisting of polycaprolactone) in which the surface was functionalized with catecholic polydopamine (coating layer comprising a catechol compound) (Abs, Fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the polymeric medical devices (scaffolds) coated with catechol of LEE to be a three dimensional scaffold consisting of polycaprolactone as taught by TASKIN because the 3D structure allows for significantly higher cell infiltration depth over time compared to 2D (p. 15868, Cellular Infiltration, Fig 4D) and overcomes the limited porosity of conventional 2D scaffolds that leads to limited proliferation rate as 3D scaffolds have enhanced viability/proliferation after 28 days of culture compared to the 2D ones (Fig 3F) and PCL is one of the most common FDA approved synthetic polymers (p.15870, Discussion paragraph 3).
Regarding claim 8, LEE discloses the coated material can be used as a cell culture scaffold (line 316) and that stem cells can be cultured (line 273) but does not explicitly disclose culturing a salivary gland on the coating layer.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of LEE to include culturing a salivary gland on the coating layer as the type of cell chosen. Based on the benefits of the coating taught by LEE (lines 233-235, 320-326) it would have been obvious to try choosing from a finite number of identified, predictable types of cells or tissues to culture through routine experimentation with a reasonable expectation of success.
Regarding claim 9, LEE discloses the method of forming the coating layer comprises immersing the support in the coating solution [0097].
Response to Arguments
Applicant's arguments filed 1/16/26 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Specifically applicant argues that one would not be motivated to change the polycaprolactone functionalized with catecholic polydopamine of TASKIN, the examiner points out that the rejection relied upon TASKIN for teaching specifically a polycaprolactone scaffold as a substitution for the three dimensional scaffold of LEE and did not rely on TASKIN to teach the coating layer. The above combination relies upon maintaining the coating layer as taught by LEE and replacing only the scaffold with that taught by TASKIN.
It is noted, that the independent claim 7 was not amended as in current claim 1 (which now incorporates previous dependent claim 6) and applicant has provided no specific arguments against the previous rejection.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799